MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-31

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The field service engineer initially replaced both the endoscopic controller and video processor.When programming and power cycling the system, a 319 error appeared.The fse then restored the original ec, programmed and power cycled the system, and no error occurred.The vp was found to be the faulty component.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the vp involved with this complaint and completed the device evaluation.Failure analysis investigation could not replicate the reported complaint; however, confirmed the error faults occurred via the system error logs.It was noted that error 31030 indicated the vp subsystem timed out.The vp was installed and tested on the pca test system.The vp started up with no errors, and good image in both eyes was noted.The system ran 10 power cycles with the vp installed and passed.The unit remained in the test system for 1 hour in normal mode, while testing other boards, and it performed with no anomalies.When the logs were reviewed, fa found 6 instances of error 31030 logged by the vp.It was recommended the universal controller card be replaced as a precaution.A review of the site's complaint history does not show any additional complaints related to this product.This complaint is being reported due to the davinci system malfunction rendering the davinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if the reported malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted ovarian cystectomy surgical procedure, the customer received a non-recoverable 31030 error.The technical service engineer (tse) viewed the system logs and noted error 331030 and 252 pointing to the video processor (vp) module.At that point, the doctor decided to convert to laparoscopic surgery.The tse had the customer remove the instrument and turn off the system.Then, the tse had the customer perform a hard cycle on the vision side cart (vsc) and reseat all the fiber cables; including the grey fiber to the vp module.The staff rebooted the system and no errors came up.The tse then instructed the staff that they could use the robot now, but the error could possibly return.The customer requested the field service engineer (fse) follow up.There was no reported injury or harm.Isi followed up with the gyn lead and obtained the following additional information: the gyn lead reported that the system was unavailable, the surgeon did not want to wait and decided to convert the procedure to laparoscopic.It was noted the system was inspected prior to use and no issues were noted during setup nor port placement.The procedure was reportedly half way through when the reported issue occurred.It was confirmed that the patient had not returned to the hospital for any post-operative complications.No video or image was available for review.The gyn lead confirmed the procedure was completed with no reported injury or harm to the patient.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10366109
• MDR Text Key: 241926042
• Report Number: 2955842-2020-10712
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-31
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1